Drug Development

Articles

Investment group Ardian will acquire the fine chemicals business activities of DPx Holdings B.V.

DPx Holdings Sells Fine Chemicals Business

The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.

EMA Releases API Bioequivalence Studies Guidance

AMRI expands its API portfolio and European presence through acquisition of Gadea’s Crystal Pharma Group.

AMRI Acquires Gadea Pharmaceutical Group

Catalent’s licensing of Excelimmune’s antibody combination therapy platform can enable the manufacture of multiple recombinant antibodies in a single batch culture.

Catalent Licenses Excelimmune’s Antibody Combination Therapy Platform

Biogen plans to build a biologics manufacturing plant in northwest Switzerland using next-generation technologies to create efficiency and sustainability.

Biogen Plans Biologics Manufacturing Facility in Switzerland

Biologics exhibit greater variability in stability testing than do small-molecule drugs, and maintaining a stable test environment is crucial.

Testing the Stability of Biologics

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

FDA, Congress, and early adopters look to speed up the use of continuous API manufacturing.

Lack of Expertise Hinders Adoption of Continuous API Synthesis

GSK will invest in an additional downstream isolation facility for amoxicillin production in Singapore.

GSK Plans Increase in Antibiotic Production in Singapore

Eric Langer has over 25 years experience in biotechnology and life sciences strategic marketing management, market research, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies. He has published and authored many books and reports on topics in Biotechnology, Large-scale BioManufacturing, and bioscience commercialization and communication. He teaches at Johns Hopkins University marketing management, biotech marketing, services marketing, and marketing in a regulated environment. In 1989 he co-founded BioPlan Associates, Inc. to provide market analysis, and strategy to biotech and healthcare organizations.

More biopharma companies choose outside service providers for assay testing.

Assay Testing Shifts to Outsourced Operations

Novasep's new antibody drug conjugate facility at its site in Le Mans, France will be commissioned in 2016.

APIs and Excipients